As expected, Biomarin Pharmaceutical Inc.’s Vimizim (elosulfase alfa), an enzyme replacement therapy for mucopolysaccharidosis (MPS) Type IVA, also called Morquio A syndrome, sailed through an FDA advisory panel with positive voting. Read More
Procrastination paid off this time for drugmakers who delayed putting systems in place to comply with a California law requiring half the drugs a company markets in the state to be serialized by 2015. Read More
Cardiome Pharma Corp. and privately held specialty pharma Correvio LLC consummated a marriage of convenience that may create a company stronger than the sum of the two partners. Read More
Topokine Therapeutics Inc. has begun dosing in a Phase II trial of its XAF5 gel for reduction of excess submental fat, or double chin. The product is a formulation of XAF5, which reduces cellular lipid content and differentiation in adipocytes. Read More
Shares of Pozen Inc. jumped 14.6 percent Tuesday on news that U.S. commercialization of Vimovo, its approved gastric-friendly nonsteroidal inflammatory drug, would be transferring to specialty pharma Horizon Pharma USA Inc., a company that has shown early success in marketing its own similar combo product, Duexis. Read More
• Alliqua Inc., of Langhorne, Pa., inked a licensing agreement with Celgene Cellular Therapeutics, a subsidiary of Celgene Corp., of Summit, N.J., for development and marketing rights to wound care products Biovance and Extracellular Matrix (ECM). Read More
• Biocardia Inc., of San Carlos, Calif., reported 12-month results for the Phase II Transendocardial Autologous Cells (mesenchymal cells, or MSC, or bone marrow mononuclear cells, or BMC) in Ischemic Heart Failure Trial (TAC-HFT). Read More
• Simcere Pharmaceutical Group, of Nanjing, China, said it called an extraordinary general meeting for Dec. 19 to consider and vote on, among other items, the proposal to approve the plan of merger dated Aug. 28, 2013, between Simcere Holding Ltd. and Simcere Acquisition Ltd. Read More
• Boehringer Ingelheim GmbH, of Ingelheim, Germany, reported clinical results from a study of 145 healthy male volunteers showing that its fully humanized antibody fragment (Fab) rapidly reversed the anticoagulation effect of dabigatran, with onset of action detected immediately following a five-minute infusion. Read More
• Oxford Biomedica plc, of Oxford, UK, signed a loan facility agreement for £5 million (US$8 million) secured loan facility agreement with Vulpes Life Sciences Fund, its largest shareholder. Read More
